Additionally, the independent
data and safety monitoring board has reviewed all safety data from the global Phase 3 program available to-date and has not identified any safety signals or vaccine-related adverse events.
Neovacs SA (EPA: ALNEV) has received a positive data review from the Independent
Data and Safety Monitoring Board (IDSMB) for the ongoing Phase IIb clinical trial of IFNalpha Kinoid in lupus, the French biotech company announced on Tuesday.
(ASTM) announced that the independent
Data and Safety Monitoring Board (DSMB) for the company's ixCELL-DCM Phase 2b clinical trial has recommended continuing the study without modification as planned following an interim review of unblinded safety data from the trial.
The International Conference on Harmonisation's (ICH) guidance on good clinical practice [2] and on statistical principles for clinical trials [3] defines a DMC (also called
Data and Safety Monitoring Board or Monitoring Committee) as 'an independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial'.
M2 EQUITYBITES-January 25, 2016-NephroGenex completes safety review of independent Data and Safety Monitoring Board for Pyridorin
NephroGenex, a company that develops drugs to treat kidney disease, with a first indication in diabetic nephropathy, has announced that the independent Data and Safety Monitoring Board (DSMB) for the company's pivotal Phase three study of oral Pyridorin, has completed the second, pre-planned six-month safety review, it was reported on Friday.
M2 PHARMA-January 25, 2016-NephroGenex completes safety review of independent
Data and Safety Monitoring Board for Pyridorin
Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NIH program staff to a
data and safety monitoring board. These monitoring activities are distinct from the requirement for study review and approval by an institutional review board.
Entitled 'The Role of
Data and Safety Monitoring Boards in Human Subject Research', the conference brought physicians, researchers and healthcare professionals together at WCM-Q to hear expert speakers from around the globe explain the ethics and safeguards used when conducting studies on humans.
Entitled 'The Role of
Data and Safety Monitoring Boards in Human Subject Research', the conference brought physicians, researchersand healthcare professionals together at WCM-Q to hear expert speakers from around the globe explainthe ethics and safeguards used when conducting studies on humans.
Independent
data and safety monitoring boards (DSMBs) should be established to monitor risks to subjects and protect them from harm.
1) Identify and evaluate strategies to improve the oversight of human participants protection by IRBs,
data and safety monitoring boards (DSMB), conflict of interest (COI) committees, etc.
